A Study to Evaluate Lenalidomide Combined With Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma

August 27, 2009 updated by: Celgene Corporation

A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Lenalidomide (Revlimid ®) in Combination With Dexamethasone in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

To evaluate the safety and efficacy of lenalidomide (Revlimid ®) in combination with dexamethasone in subjects with relapsed or refractory diffuse large B-cell lymphoma.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Non-Hodgkin's lymphoma (NHL) can be divided into two general prognostic groups: the indolent lymphomas and the aggressive lymphomas. Indolent lymphomas have a relatively good prognosis, with median survival time as long as 10 years, but they are not usually curable in advanced stages. Aggressive NHL constitutes about half of all cases of NHL in North America and Western Europe. Of the aggressive lymphomas, diffuse large B-cell lymphoma (DLBCL) is the most common type, accounting for up to 30 percent of newly diagnosed cases. The aggressive type of NHL has a shorter natural history; approximately 50-60% of these subjects can be cured with combination chemotherapy regimens. Even with recent advances, many patients with advanced stage DLBCL are not cured with conventional therapy. This leaves a subset of subjects who will eventually relapse or who are refractory to treatment.

Due to the variation in the clinical behavior of the different types of aggressive NHL, it is important to test lenalidomide in DLBCL. Other studies are addressing the activity of lenalidomide in the other types of aggressive lymphomas, as well as in indolent NHL. It is important to test lenalidomide in combination therapy. This study is focused on treating subjects with relapsed or refractory DLBCL using oral lenalidomide in combination with oral dexamethasone.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Frankston, Australia, VIC 3199
        • Frankston Hospital
      • South Brisbane, Australia, QLD 4101
        • HOCA
      • Wodonga, Australia, VIC 3690
        • Border Medical Oncology
    • Victoria
      • Melbourne, Victoria, Australia, VIC3050
        • The Alfred Hospital
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
  • United States
    • Arizona
      • Glendale, Arizona, United States, 85304
        • Palo Verde Hematology/Oncology, Ltd.
    • California
      • Beverly Hills, California, United States, 90211
        • Tower Cancer Research Foundation
    • Florida
      • Miami, Florida, United States, 33176
        • Advanced Medical Specialties
      • Port St. Lucie, Florida, United States, 34952
        • Hematology/Oncology Associates of Treasure Coast
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Cancer Care & Hematology Specialists of Chicagoland
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern University, Feinberg School of Medicine
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Southwest Oncology Associates
    • Maryland
      • Hagerstown, Maryland, United States, 21742
        • Washington County Hospital, The Center for Clinical Research
    • Michigan
      • Kalamazoo, Michigan, United States, 49048
        • Kalamazoo Hematology & Oncology
    • New Jersey
      • Denville, New Jersey, United States, 07834
        • Oncology & Hematology Specialists, PA
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • North Carolina
      • Hickory, North Carolina, United States, 28602
        • Northwestern Carolina, Oncology and Hematology PA
      • New Bern, North Carolina, United States, 28562
        • New Bern Cancer Care
    • Ohio
      • Columbus, Ohio, United States, 43210
        • James Cancer Hospital
    • Texas
      • Austin, Texas, United States, 78705
        • Southwest Regional Cancer Center
    • Utah
      • Ogden, Utah, United States, 84403
        • Northern Utah Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Biopsy-proven diffuse large B-cell non-Hodgkin's lymphoma
  • Relapsed or refractory to previous therapy for non-Hodgkin's lymphoma
  • Measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
  • ECOG performance score of 0,1 or 2
  • Willing to follow the pregnancy precautions

Exclusion Criteria:

  • Any of the following laboratory abnormalities.
  • Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L).
  • Platelet count < 60,000/mm3 (60 x 109/L).
  • Serum SGOT/AST or SGPT/ALT 5.0 x upper limit of normal (ULN).
  • Serum total bilirubin > 2.0 mg/dL (34 µmol/L).
  • Subjects who are candidates for and willing to undergo an autologous stem cell transplant.
  • History of active CNS lymphoma within the previous 3 months
  • Subjects not willing or unable to take DVT prophylaxis
  • History of other malignancies within the past year
  • Positive HIV or active Hepatitis B or C

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm
Drug: CC-5013 (lenalidomide)
Lenalidomide 25 mg, orally, once daily, on Days 1 to 21 of every 28-day cycle administerd in combination with dexamethasone 40 mg, orally, once daily, on Days 1, 8, 15, and 22 of every 28-day cycle
Other Names:
  • CC-5013
  • Revlimid
  • lenalidomide
Drug: dexamethasone
Dexamethasone 40 mg, orally, once daily, on Days 1, 8, 15, and 22 of every 28-day cycle administered in combination with lenalidomide 25 mg, orally, once daily, on Days 1 to 21 of every 28-day cycle.
Other Names:
  • Decadron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor Response Rate
Time Frame: One Year

Number of participants demonstrating complete or partial tumor response (Cheson B, Horning S, Coiffier B, Shipp M, Fisher R, Connors J, et al, Report of an international workshop to standardize response criteria for non-Hodgkins' lymphoma. J Clin Oncol.1999;17:1244-53).

Study terminated prematurely. Analysis not conducted.
One Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor Control Rate
Time Frame: One Year

Number of participants demonstrating complete tumor response, partial tumor response, or stable disease.

Study terminated prematurely. Analysis not conducted.
One Year
Duration of Response
Time Frame: One year

Time from first demonstration of at least a partial response to the first documentation of disease progression, including death due to non-Hodgkin's lymphoma.

Study terminated prematurely. Analysis not conducted.
One year
Time to Progression
Time Frame: One year

Time from the start of study drug therapy to the first documentation of disease progression.

Study terminated prematurely. Analysis not conducted.
One year
Progression-free Survival
Time Frame: One year

Time from the start of study drug therapy to the first observation of disease progression or death due to any cause.

Study terminated prematurely. Analysis not conducted.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene Corporation

Investigators

  • Principal Investigator: Andrew Spencer, MD, The Alfred

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

May 14, 2007

First Submitted That Met QC Criteria

May 15, 2007

First Posted (Estimate)

May 16, 2007

Study Record Updates

Last Update Posted (Estimate)

September 2, 2009

Last Update Submitted That Met QC Criteria

August 27, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-5013-NHL-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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